FDA

Are Clinicians Using the PLLR to Guide Prescribing During Pregnancy?

In 2015, the U.S. Food and Drug Administration (FDA) proposed major revisions to prescription drug labeling -- the Pregnancy and Lactation Labeling Rule or PLLR -- in order to provide more accurate and helpful information [...]

Taking a Look at the New FDA Pregnancy Labeling and Lactation Rule

The U.S. Food and Drug Administration (FDA) has proposed major revisions to prescription drug labeling in order to provide more accurate and helpful information on the effects of medications used during pregnancy and breastfeeding. The [...]

FDA Finalizes Guidelines for Pregnancy and Lactation Labeling Information

Last week, the U.S. Food and Drug Administration (FDA) published a report outlining the new standards for how to present information regarding the safety of medications used during pregnancy and breastfeeding: “The new content and formatting requirements will provide a more consistent way to include relevant information about the risks and benefits of prescription drugs and biological products used during pregnancy and breastfeeding.”  These changes will be put into effect by June 2015.

Valproic Acid and Pregnancy: FDA Issues Warning

There have been multiple recent reports indicating that the use of valproate during pregnancy may be associated with lower IQ, cognitive problems, and developmental delays in exposed children.  This has prompted the FDA to issue a warning regarding the use of valproate-containing drugs, including Depakote and Depakene, during pregnancy: